It’s a first. The American health authorities have authorized, this Monday, August 22, a vaccine administered to pregnant women with the aim of protecting babies against bronchiolitis, a potentially dangerous respiratory infection, particularly for toddlers.
The vaccine from pharmaceutical giant Pfizer, marketed under the name Abrysvo, targets respiratory syncytial virus (RSV), which can cause pneumonia and bronchiolitis in its most severe forms.
Waiting for the decision of the European Commission
The vaccine is licensed for pregnant women between 32 and 36 weeks of gestational age, the US Drug Administration (FDA) said in a statement. The single injection will be made into a muscle. Children will be protected during their first six months of life, explains the FDA, thanks to antibodies transmitted by the mother.
This same vaccine had already been approved since May in the United States for people aged 60 and over.
It was also approved in July by the European Medicines Agency (EMA) – both for babies and for the elderly – but the European Commission must now decide on its marketing authorization within the European Union.
This virus “is a common cause of illness in children, and infants are among those most at risk of developing serious illness, which can lead to hospitalizations,” said FDA official Peter Marks. , welcoming this new option against a “potentially fatal” disease.
Between 100 and 300 deaths in children under 5
Outbreaks of RSV, a highly contagious virus, are seasonal. Last winter, hospitals were stormed on both sides of the Atlantic in the face of an epidemic of staggering proportions.
The Centers for Disease Control and Prevention (CDC), the main federal public health agency in the United States, will in turn have to recommend the vaccine before the injections begin.
The United States records between 58,000 and 80,000 virus-related hospitalizations in children under 5 each year, and 100 to 300 deaths, according to the CDC. It is the leading cause of hospitalization for toddlers in the country.
The lab race
After decades of research, pharmaceutical companies are engaged in a race for a multi-billion dollar market. The British pharmaceutical giant GSK had obtained in early May the first authorization in the world for a vaccine against bronchiolitis, granted by the FDA for adults aged 60 and over. Pfizer then quickly obtained a similar authorization. Moderna is also in the running.
The European Union and the United States have also recently authorized a preventive treatment for bronchiolitis developed jointly by AstraZeneca and Sanofi. Intended for infants, nirsevimab (marketed under the name Beyfortus) is not strictly speaking a vaccine, but works with the same preventive intention.
The CDC recommended in early August an injection of these monoclonal antibodies for all children under eight months old, born during or entering their first epidemic season.